Clozapine IP BP USP Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Clozapine Muby Chemicals of Mubychem Group, established in 1976, is the original manufacturers of Specialty Chemicals, Pharmaceutical Excipient, Fragrance Food & Flavor chemicals, Reagent Grade Chemicals, Shale Gas Fracturing Chemicals in India. Mubychem Group has several manufacturing facilities spread across Western India and world wide contacts and toll manufacturers. We are exporting globally to countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Cameroon, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Korea, Vietnam, Thailand, Malaysia, Indonesia, Australia, China, Germany, France, Italy, Portugal etc.

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Clozapine: CAS Number: 5786-21-0, EINECS EC Number: 227-313-7, Molecular Formula: C18H19ClN4, Molecular Weight: 326.83, HS Code ---**

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Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Clozapine.

For SDS MSDS Sheet Click
SDS MSDS Sheet of Clozapine Manufacturers

Clozapine
IP BP USP Pure Suppliers
Clozapine

Clozapine is an a typical antipsychotic medication apart from other uses. It is mainly used for schizophrenia that does not improve following the use of other antipsychotic medications.

Clozapine USP Grade
C18H19ClN4 --- 326.83
5H-Dibenzo[b,e][1,4]diazepine, 8-chloro-11-(4-methyl-1-piperazinyl)-.
8-Chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine [5786-21-0].

Clozapine contains not less than 98.0 percent and not more than 102.0 percent of C18H19ClN4, calculated on the dried basis.

Packaging and storage: Preserve in well-closed containers.
Identification:
A: Infrared Absorption.
B: The RF value of the principal spot observed in the chromatogram of the Test solution corresponds to those of the principal spots observed in the chromatograms of the Standard solutions, as obtained in the test for Chromatographic purity.
Melting range: between 182C and 186C.
Loss on drying: Dry it at 105C for 4 hours: it loses not more than 0.5% of its weight.
Residue on ignition: not more than 0.1%.
Heavy metals: 0.002%.
Chromatographic purity: To pass the test.
Assay: Transfer about 115 mg of Clozapine, accurately weighed, to a suitable container, dissolve in 70 mL of glacial acetic acid, and titrate with 0.1 N perchloric acid, determining the endpoint potentiometrically. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 16.34 mg of C18H19ClN4.


Clozapine BP Ph Eur Grade
Ph. Eur.
C18H19ClN4 --- 326.8 --- 5786-21-0 
Action and use: Dopamine D4 receptor antagonist; neuroleptic.

DEFINITION
8-Chloro-11-(4-methylpiperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine.
Content: 99.0 per cent to 101.0 per cent (dried substance).

CHARACTERS
Appearance: Yellow, crystalline powder.
Solubility: Practically insoluble in water, freely soluble in methylene chloride, soluble in ethanol (96 per cent). It dissolves in dilute acetic acid.

IDENTIFICATION
A. Melting point: 182C to 186C.
B. Infrared absorption spectrophotometry.

TESTS
Related substances: To pass the test by liquid chromatography.
Loss on drying: Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105C.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.

ASSAY
Dissolve 0.100 g in 50 mL of anhydrous acetic acid. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically. 1 mL of 0.1 M perchloric acid is equivalent to 16.34 mg of C18H19ClN4.

IMPURITIES
Specified impurities A, B, C, D
A. 8-chloro-5,10-dihydro-11H-dibenzo[b,e][1,4]diazepin-11-one,
B. 11,11′-(piperazine-1,4-diyl)bis(8-chloro-5H-dibenzo[b,e][1,4]diazepine),
C. 8-chloro-11-(piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine,
D. 1-[2-[(2-amino-4-chlorophenyl)amino]benzoyl]-4-methylpiperazine.


Clozapine IP Grade
Clozapine is also in IP Pharmacopoeia.

For Original Monographs of IP Indian Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.

We also manufacture and supply as under:

Amlodipine Besylate

Clevidipine Butyrate

Clozapine

N-Isopropylnortropine

Scopine Hydrochloride

Felodipine.

Manufacturers:

MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +912223770100, +912223726950
Current Date Time in India GMT+5:30

e-mail: info@mubychem.com

USA, Canada, Mexico and other American
neighbouring buyers may
e-mail: us@mubychem.com
Call toll-free 1-877-682-9243 (1-877-MUBYCHEM)

Manufacturers india
Copyright and Usual Disclaimer is Applicable.
Last 9 February, 2024

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Clozapine SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet
10-Oct-20

1. Product Identification

Product Name & Other Names: Clozapine.
CAS Number: 5786-21-0
EINECS EC Number: 227-313-7
Molecular Formula: C18H19ClN4
Molecular Weight: 326.83
Intended Use: Industrial Manufacturing.
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.

2. Hazards Identification
GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008

Acute toxicity, Oral: Category 3, H301
Specific target organ toxicity, single exposure; Narcotic effects Category 3, H336
Germ cell mutagenicity Category 2, H341
Reproductive toxicity Category 2, H361

Labeling according GHS USA & Regulation (EC) No 1272/2008

GHS Label Elements
Toxic
Toxic

GHS Label Elements
Health Hazzard
Health Hazard

Signal Words: Danger

Hazard Statements:
H301: Toxic if swallowed.
H341: Suspected of causing genetic defects.
H336: May cause drowsiness and dizziness.
H361: Suspected of damaging fertility or the unborn child.

Precautionary Statements:
P202: Do not handle until all safety precautions have been read and understood.
P260: Do not breathe dust/fume/gas/mist/vapors/spray.
P262: Do not get in eyes, on skin, or on clothing.
P264: Wash contaminated parts thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P301+P310: IF SWALLOWED: Immediately call a POSION CENTER or doctor/physician.
P314: Get medical advice/attention if you feel unwell.
P302+352: IF ON SKIN: Wash with plenty of soap and water.
P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing.

Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbols:
T Toxic
Xn Harmful
Risk Phrases:
R25 Toxic if swallowed.
R46 May cause inheritable genetic damage
R60 May impair fertility
R61 May cause harm to the unborn child.
R67 Vapors may cause drowsiness and dizziness.

3. Composition/Information on Ingredients

Product Name & Other Names: Clozapine.
CAS Number: 5786-21-0
EINECS EC Number: 227-313-7

4. First Aid Measures

Inhalation: Remove affected person to fresh air; if normal breathing has not returned within a few minutes after exposure, get medical attention.
Skin
: Remove contaminated clothing; wash affected area with soap and water; launder contaminated clothing before reuse. Seek medical attention.
Eyes
: Immediately, flush eyes for 15 minutes in clear running water while holding eyelids open; seek medical attention immediately.
Ingestion: Drink two glasses of water followed by milk, milk of magnesia or other non-alcoholic liquids; Do not induce vomiting; seek medical attention immediately.
Physician may treat symptomatically.

5. Fire Fighting Measures

Flammable Limits: No unusual fire or explosion hazards noted.
General Hazards: Contact with eyes causes immediate severe irritation of the eye and eyelids. Product will support combustion.
Extinguishing Media: Carbon dioxide, water fog, dry chemical, chemical foam.
Organics solids, may be ignitable. Keep containers cool by spraying with water. Use extinguishing media appropriate for surrounding fire.
Fire & Explosion Hazard: May evolve toxic fumes, oxides of carbon (COx), oxides of nitrogen (NOx) under fire conditions.
In case of fire, wear a full face positive-pressure self-contained breathing apparatus and protective suit. Self - contained respiratory equipment; cool containers to prevent pressure buildup and possible explosion when exposed to extreme heat. Caution - material will support combustion!
Hazardous Combustion Products: Products of combustion include smoke, toxic fumes, oxides of carbon to include carbon monoxide, nitrogen oxides, hydrogen chloride.
Specific Methods: Cool containers exposed to flames with water until well after the fire is out.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode. At high temperatures under fire conditions, it may produce toxic or irritating fumes.

6. Accidental Release Measures

Personal precautions, protective equipment, and emergency procedures: It may support combustion. Do not touch damaged containers or spilled material unless wearing appropriate protective clothing. Avoid breathing dust/fumes/gas/mist/vapors/spray. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Restrict unprotected personnel from the area. Prevent any contact with hot surfaces. Do not approach facing the wind. Do not touch the spilled material.
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment Cleanup procedures and Storage: Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g. sand, earth, diatomaceous earth, vermiculite). Vacuum or sweep-up and remove to an approved disposal container.

7. Handling and Storage

Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. Wash thoroughly after handling. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Provide appropriate exhaust ventilation at places where dust is formed. Avoid contact with eyes, skin, and clothing. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Prevent any contact with hot surfaces.
Conditions for safe storage, including any incompatibilities: Store in cool, dry, and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Do not leave the material container open. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid contact with skin and eyes. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like strong bases & oxidizing agent. Keep this and other chemicals out of reach of children.

8. Exposure Controls/Personal Protection

Engineering Controls: The use of local exhaust ventilation is recommended to control emissions near the source. Provide mechanical ventilation of confined spaces. Use corrosion-resistant, explosion-proof ventilation equipment.
Exposure Limits: Not established.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator may be worn. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Dust deposits on floors and other surfaces may pick up moisture and cause the surfaces to become slippery and present safety hazards. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.

9. Physical and Chemical Properties

Appearance: Yellow, crystalline powder.
Odor: Not available.
Odor threshold: Not available.
pH: Not available.
Relative density: Not available.
Melting/Freezing Point:  182C to 186C.
Initial boiling point and boiling range: Not available.
Flash point: Not available.
Auto-ignition temperature: Not available.
Decomposition temperature: Not available.
Upper/lower flammability or explosive limits: Not available.
Vapor pressure: Not available.
Vapor density: Not available.
Evaporation rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility in Water: Negligible.
Viscosity: Not available.
Molecular Formula: C18H19ClN4
Molecular Weight: 326.83

10. Stability and Reactivity

Stability: Stable at normal temperatures and operating conditions.
Conditions to Avoid: Avoid excessively high temperatures and contact with alkalis or strong oxidizing agents.
Incompatibilities: Strong Bases & Oxidizing Agent.
Decomposition: Decomposition yields toxic fumes, oxides of carbon (COx), oxides of nitrogen (NOx), hydrogen chloride.
Polymerization: Polymerization will not occur.

11. Toxicological Information

Toxic if swallowed.
Toxicity Data:
LD50 Oral - Rat - 251 mg/kg
LD50 Subcutaneous - Rat - 240 mg/kg
LD50 Intramuscular - Rat - 210 mg/kg
LD50 Intravenous - Rat - 41,6 mg/kg.
Reproduction: Suspected human reproductive toxicant.
Mutagenicity: Investigated as a drug, mutagen, and reproductive effector.
Carcinogenicity: Not listed as a human carcinogen by OSHA, IARC, ACGIH & NTP.
Remarks on Possible Effects: Dizziness. Fainting. Fever. Weight gain. Anxiety. Irritability. Restlessness. Confusion. Blurred vision. Tremor. Headache. Constipation. Drowsiness. Salivation. Nausea. Vomiting. Heartburn. Sweating. Nervousness. Hallucinations. Seizures. Narcotic effects.

12. Ecological Information

Toxicity to fish: Not available.
Neither COD nor BOD data are available.
Results of PBT and vPvB assessment: No data available.
Persistence and degradability: No data available.
Bioaccumulative potential: No data available.
Mobility: No data available.

13. Disposal Considerations

Dispose of in accordance with Local, State, and Federal Regulations. Consult local, state, or Federal Environmental Protection Agency before disposing of any chemicals.

14. Transport Information

DOT USA & ADR/RID Europe
Proper Shipping Name: TOXIC SOLID, ORGANIC, N.O.S. (CLOZAPINE)
UN#: 2811
Class: 6.1; Packing Group: Packing Group III
IATA & IMDG
Proper Shipping Name: TOXIC SOLID, ORGANIC, N.O.S. (CLOZAPINE)
UN#: 2811
Class: 6.1; Packing Group: Packing Group III

15. Regulatory Information

No significant information is available.

Section 16 - Additional Information

European Labeling in Accordance with EC Directives:
H301: Toxic if swallowed.
H341: Suspected of causing genetic defects.
H336: May cause drowsiness and dizziness.
H361: Suspected of damaging fertility or the unborn child.

Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbols:
T Toxic
Xn Harmful
Risk Phrases:
R25 Toxic if swallowed.
R46 May cause inheritable genetic damage
R60 May impair fertility
R61 May cause harm to the unborn child.
R67 Vapors may cause drowsiness and dizziness.

Disclaimer:
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Our company provides this MSDS sheet in good faith but makes no representation as to its comprehensiveness or accuracy. This SDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. The above information has been compiled from various sources and has the possibility of discrepancy and being out-dated information. Individuals receiving the information must exercise their independent judgment and do further search in determining its appropriateness for a particular purpose. In no case shall our company be liable to loss or damages by the product user.
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